Eurasian Economic Union as a market for pharmaceuticals. Based on a UNDP report this presentation describes the market, its characteristics and some potential protections.
Marketing Authorization Procedure in European UnionDoninder Hooda
ย
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
The European Medicines Agency (EMA) regulates medicines for both human and veterinary use across Europe. Key responsibilities of EMA include evaluating applications for new medicines and monitoring approved medicines. EMA operates through various scientific committees and follows regulatory procedures for clinical trials and marketing authorization applications. EMA helps ensure that medicines available across Europe are safe, effective and of high quality.
Bodies regulating indian pharmaceutical sector, cdscochiranjibi68
ย
This document provides an overview of the major regulatory bodies that govern the Indian pharmaceutical sector, with a focus on the Central Drugs Standard Control Organization (CDSCO). It begins with background on drug regulation and the need for effective regulation. It then discusses various international and Indian regulatory bodies. The bulk of the document describes the roles and functions of CDSCO and the Drug Controller General of India as the central drug authorities that approve clinical trials, marketing authorization, and licenses for certain drug categories. It also briefly discusses the National Pharmaceutical Pricing Authority and deficiencies in India's drug regulatory system.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
The document discusses international drug regulatory affairs. It provides an overview of the regulatory structures and agencies that govern the pharmaceutical industry. The key regulatory bodies discussed include the FDA in the US, EMEA in Europe, and other agencies in countries like Japan, Australia, Brazil, Nigeria, China, and India. The document also summarizes the various approval processes for new drugs and generics, including requirements for clinical trials, applications, and common technical dossier formats. Common challenges in international regulatory approval are also briefly mentioned.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
Marketing Authorization Procedure in European UnionDoninder Hooda
ย
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
The European Medicines Agency (EMA) regulates medicines for both human and veterinary use across Europe. Key responsibilities of EMA include evaluating applications for new medicines and monitoring approved medicines. EMA operates through various scientific committees and follows regulatory procedures for clinical trials and marketing authorization applications. EMA helps ensure that medicines available across Europe are safe, effective and of high quality.
Bodies regulating indian pharmaceutical sector, cdscochiranjibi68
ย
This document provides an overview of the major regulatory bodies that govern the Indian pharmaceutical sector, with a focus on the Central Drugs Standard Control Organization (CDSCO). It begins with background on drug regulation and the need for effective regulation. It then discusses various international and Indian regulatory bodies. The bulk of the document describes the roles and functions of CDSCO and the Drug Controller General of India as the central drug authorities that approve clinical trials, marketing authorization, and licenses for certain drug categories. It also briefly discusses the National Pharmaceutical Pricing Authority and deficiencies in India's drug regulatory system.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
The document discusses international drug regulatory affairs. It provides an overview of the regulatory structures and agencies that govern the pharmaceutical industry. The key regulatory bodies discussed include the FDA in the US, EMEA in Europe, and other agencies in countries like Japan, Australia, Brazil, Nigeria, China, and India. The document also summarizes the various approval processes for new drugs and generics, including requirements for clinical trials, applications, and common technical dossier formats. Common challenges in international regulatory approval are also briefly mentioned.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
Pharmaceutical pricing and reimbursement usaNeha Kalal
ย
This document provides an overview of pharmaceutical pricing and reimbursement in the United States. It discusses key demographics and economic factors, the major public and private healthcare programs, and how drug pricing and reimbursement works. The US healthcare system is complex, with prescription drugs constituting 12% of total spending. Major public programs include Medicare, Medicaid, and CHIP, while private sources include employer and individual insurance plans. Pharmaceutical companies set prices freely, while payers determine reimbursement levels and use formularies, tiers, and cost-sharing to manage drug costs.
Ann Rockley โ Managing the Complexities of the Core Data Sheet (CDS)Ann Rockley
ย
The Core Data Sheet (CDS) is a critical component of the effective creation of Labeling content for different regulatory regions and outputs (Prescribing Information/Package Insert, Package Leaflet, etc.). The content is typically managed in email, complex MS Word documents, or Excel spreadsheets. It is difficult to track content relationships and ensure accuracy as the content moves out of the CDS to the desired deliverables. It is a painstaking and error-prone process.
Learn how you can use intelligent content best practices to design a structured component-based CDS. You will learn how to identify a reuse strategy to ensure content is correctly reused and tracked wherever it appears; manage the content using a structured content management system; automatically track content relationships; and manage claims and associated references throughout the content lifecycle.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
ย
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, weโll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, weโll discuss the eCTD roadmap for the future and the end of paper submissions.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Regulatory intelligence plays an important role in the pharmaceutical industry by helping companies stay compliant, influence regulations, and make strategic decisions. Key responsibilities of regulatory intelligence functions are to identify regulatory changes, conduct analyses to facilitate decision making, and serve as internal consultants. Having access to sources like regulatory authorities and trade associations helps with identifying opportunities, reducing costs and time to market, and increasing compliance. However, challenges include the large volume of information, regional differences, and unclear agency expectations that require regulatory professionals to "read between the lines".
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
ย
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
ย
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Pharmaceutical Regulations in GCC countriesIman Ajami
ย
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
Registration procedure of drugs in european unionbdvfgbdhg
ย
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The Ministry of Health, Labour and Welfare (MHLW) is Japan's governmental authority that issues regulations and guidelines for pharmaceuticals. The Pharmaceuticals and Medical Devices Agency (PMDA) works with MHLW as Japan's main regulatory body, located in Tokyo. PMDA is responsible for reviewing marketing applications, monitoring post-marketing safety of drugs and devices, and providing compensation for adverse reactions. The drug approval process in Japan involves IND applications reviewed by PMDA and IRB, as well as regulatory reviews and approvals conducted according to a common technical document format.
The document provides information on variations and renewals of marketing authorizations in the European Union. It discusses the different types of variations (Type IA, IB, II and extensions), including examples. It describes the classification guidelines and regulations governing variations in the EU. It also outlines the documentation requirements, timelines and procedures for notification and approval of variations. Finally, it discusses marketing authorization renewals in the EU, noting they must be applied for at least 9 months before expiration for the authorization to remain valid indefinitely.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Regulatory affairs and Intellectual Property Rightssantoshnarla
ย
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
The document provides an overview of India's drug regulatory system, including:
- The Central Drugs Standard Control Organization (CDSCO) regulates drug approval, clinical trials, GMP, and other functions. It is headed by the Drug Controller General of India.
- The drug approval process involves submitting an application, treasury challan, and details on bulk drug sources. The Drugs and Cosmetics Act of 1940 and Rules of 1945 provide the legal framework and establish licensing requirements.
- There are various types of manufacturing, sale, import, and testing licenses issued under the Act based on the schedule and category of drugs. The organizational structure, approval process, legal framework and license types are described.
Kazakhstan ranked 50th on the World Economic Forum's Competitiveness Ranking and 50th on the World Bank's Ease of Doing Business ranking in 2013. Since joining the Customs Union, Kazakhstan has nearly doubled its trade turnover from $72 billion in 2009 to $133 billion in 2013 and seen foreign direct investment increase 122% between 2009 and 2013. The Eurasian Economic Union creates a common economic space and single energy market among its member countries and contains 170 million consumers and $900 billion in aggregate trade, which will lower costs and improve the business and investment climate.
The document discusses different types of trade blocs including free trade areas, customs unions, common markets, and economic unions. It provides examples of various trade blocs such as NAFTA, ASEAN, EU, OPEC, SAARC, CACM, and ALADI. The objectives of forming trade blocs are to reduce trade barriers between member countries, impose barriers on non-members, and promote economic integration and cooperation. Trade blocs can increase intra-regional trade but also create common external barriers that affect global trade.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
Pharmaceutical pricing and reimbursement usaNeha Kalal
ย
This document provides an overview of pharmaceutical pricing and reimbursement in the United States. It discusses key demographics and economic factors, the major public and private healthcare programs, and how drug pricing and reimbursement works. The US healthcare system is complex, with prescription drugs constituting 12% of total spending. Major public programs include Medicare, Medicaid, and CHIP, while private sources include employer and individual insurance plans. Pharmaceutical companies set prices freely, while payers determine reimbursement levels and use formularies, tiers, and cost-sharing to manage drug costs.
Ann Rockley โ Managing the Complexities of the Core Data Sheet (CDS)Ann Rockley
ย
The Core Data Sheet (CDS) is a critical component of the effective creation of Labeling content for different regulatory regions and outputs (Prescribing Information/Package Insert, Package Leaflet, etc.). The content is typically managed in email, complex MS Word documents, or Excel spreadsheets. It is difficult to track content relationships and ensure accuracy as the content moves out of the CDS to the desired deliverables. It is a painstaking and error-prone process.
Learn how you can use intelligent content best practices to design a structured component-based CDS. You will learn how to identify a reuse strategy to ensure content is correctly reused and tracked wherever it appears; manage the content using a structured content management system; automatically track content relationships; and manage claims and associated references throughout the content lifecycle.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
ย
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, weโll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, weโll discuss the eCTD roadmap for the future and the end of paper submissions.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Regulatory intelligence plays an important role in the pharmaceutical industry by helping companies stay compliant, influence regulations, and make strategic decisions. Key responsibilities of regulatory intelligence functions are to identify regulatory changes, conduct analyses to facilitate decision making, and serve as internal consultants. Having access to sources like regulatory authorities and trade associations helps with identifying opportunities, reducing costs and time to market, and increasing compliance. However, challenges include the large volume of information, regional differences, and unclear agency expectations that require regulatory professionals to "read between the lines".
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
ย
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
ย
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Pharmaceutical Regulations in GCC countriesIman Ajami
ย
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
Registration procedure of drugs in european unionbdvfgbdhg
ย
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The Ministry of Health, Labour and Welfare (MHLW) is Japan's governmental authority that issues regulations and guidelines for pharmaceuticals. The Pharmaceuticals and Medical Devices Agency (PMDA) works with MHLW as Japan's main regulatory body, located in Tokyo. PMDA is responsible for reviewing marketing applications, monitoring post-marketing safety of drugs and devices, and providing compensation for adverse reactions. The drug approval process in Japan involves IND applications reviewed by PMDA and IRB, as well as regulatory reviews and approvals conducted according to a common technical document format.
The document provides information on variations and renewals of marketing authorizations in the European Union. It discusses the different types of variations (Type IA, IB, II and extensions), including examples. It describes the classification guidelines and regulations governing variations in the EU. It also outlines the documentation requirements, timelines and procedures for notification and approval of variations. Finally, it discusses marketing authorization renewals in the EU, noting they must be applied for at least 9 months before expiration for the authorization to remain valid indefinitely.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Regulatory affairs and Intellectual Property Rightssantoshnarla
ย
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
The document provides an overview of India's drug regulatory system, including:
- The Central Drugs Standard Control Organization (CDSCO) regulates drug approval, clinical trials, GMP, and other functions. It is headed by the Drug Controller General of India.
- The drug approval process involves submitting an application, treasury challan, and details on bulk drug sources. The Drugs and Cosmetics Act of 1940 and Rules of 1945 provide the legal framework and establish licensing requirements.
- There are various types of manufacturing, sale, import, and testing licenses issued under the Act based on the schedule and category of drugs. The organizational structure, approval process, legal framework and license types are described.
Kazakhstan ranked 50th on the World Economic Forum's Competitiveness Ranking and 50th on the World Bank's Ease of Doing Business ranking in 2013. Since joining the Customs Union, Kazakhstan has nearly doubled its trade turnover from $72 billion in 2009 to $133 billion in 2013 and seen foreign direct investment increase 122% between 2009 and 2013. The Eurasian Economic Union creates a common economic space and single energy market among its member countries and contains 170 million consumers and $900 billion in aggregate trade, which will lower costs and improve the business and investment climate.
The document discusses different types of trade blocs including free trade areas, customs unions, common markets, and economic unions. It provides examples of various trade blocs such as NAFTA, ASEAN, EU, OPEC, SAARC, CACM, and ALADI. The objectives of forming trade blocs are to reduce trade barriers between member countries, impose barriers on non-members, and promote economic integration and cooperation. Trade blocs can increase intra-regional trade but also create common external barriers that affect global trade.
Trade Blocs in International Marketing - European Union
What is a trade bloc? Why they are formed?
Trade blocs around the world
Types of trading bloc / Levels of economic integration
Trade Bloc - EU
Benefits and Challenges of EU
Organizations within Commonwealth of Independent StatesAliaksey Narko
ย
The document discusses three intergovernmental organizations involving former Soviet states - EurAsEC, CSTO, and the Union State. EurAsEC aims to integrate member states into the world economy through a common economic space and single market. CSTO functions as a CIS alternative to NATO focused on joint military exercises. The Union State between Belarus and Russia works to harmonize their political and economic differences with shared institutions and citizenship.
This document provides information about trade blocs including the European Union (EU), South Asian Association for Regional Cooperation (SAARC), Latin American Free Trade Association (LAFTA), and North American Free Trade Agreement (NAFTA). It discusses the history, objectives, members, and effectiveness of each trade bloc. For the EU specifically, it outlines the member states, objectives of integration, organizational structure, and evolution as a trading bloc over time. Factors that the EU must consider to survive and expand are also discussed.
This researched based paper is intended to make a survey on Russian Eurasian Union project and possible politico-military trends of Russian Federation.
Jan Willem Gunning - Vrije Universiteit Amsterdam
23rd Annual Conference
Regional Cooperation Peace & Development: Issues & Lessons for MENA
Amman, Jordan 18-20, 2017
www.erf.org.eg
Unit 2 international business 6th semester bbm notes pdfIndependent
ย
This document provides information on various regional trade blocs and international organizations discussed in the International Business Unit 2 syllabus. It defines regional trade blocs and lists some examples. It also provides details on the formation and objectives of the European Union, ASEAN, OPEC, and OECD.
Louis Goodman - American University, Washington
23rd Annual Conference
Regional Cooperation Peace & Development: Issues & Lessons for MENA
Amman, Jordan 18-20, 2017
www.erf.org.eg
Project on trade blocs and trade barriersKiran Joshi
ย
1. The document discusses trade blocs, which are agreements between countries to reduce trade barriers and promote trade within the bloc.
2. It provides examples of major trade blocs like the European Union, NAFTA, SAARC, and OPEC.
3. The objectives of trade blocs are outlined as removing trade restrictions, improving relations, encouraging resource sharing, establishing collective bargaining, and promoting economic growth among member nations.
The purpose of the European Union is for its member countries to work together to gain advantages that would be difficult to achieve individually, such as increased economic power and influence on the global stage. While the EU coordinates policies on issues like trade, education, and agriculture, each country maintains independent control over its own laws, military, and government. Key benefits of EU membership include free trade, an common currency (the euro) that facilitates commerce, and freedom of movement and rights to live and work across member nations. The EU currently has 27 member countries, though some European nations have opted to remain outside the bloc.
The European Union has gone through many changes over its 57 year history, starting as the European Coal and Steel Community in 1950 with 6 founding members and growing to 27 members today. It was established to regulate trade and form a single market, and later took on goals like environmental protection, human rights, and asserting its role globally. Key events included the introduction of the Euro currency in 1999 and the expansion of membership over the decades through various treaties.
The European Union provides support to Syria through various cooperation frameworks aimed at consolidating Syria's political, social and economic reforms. The EU allocates funds through its Country Strategy Paper and National Indicative Programme to support Syria in areas like administrative modernization, decentralization, economic transition, and human resources development. The EU is also Syria's main trade partner, with trade totaling over โฌ7 billion in 2008, though Syria's exports to the EU are dominated by oil and petroleum products. Overall, EU-Syria cooperation seeks to guide Syria's own reform agenda through sharing objectives and joint projects.
This document discusses several major regional trade blocs including the European Union (EU), North American Free Trade Agreement (NAFTA), Southern Common Market (MERCOSUR), Association of Southeast Asian Nations (ASEAN), and South Asian Association for Regional Cooperation (SAARC). It provides details on the objectives, members, and key provisions or agreements of each trade bloc, such as eliminating tariffs and quotas within the blocs to promote regional trade.
Trading blocks are groups of countries that work towards reducing trade barriers between members. The document discusses the major trading blocks: the European Union, NAFTA, OPEC, ASEAN, SAARC, and MERCOSUR. It provides details on the founding, objectives, and provisions of these blocks. The European Union aims to create a common market without trade barriers between its 27 member states. NAFTA eliminated trade barriers between the US, Canada, and Mexico, creating the world's largest free trade area. OPEC coordinates policies to secure fair oil prices for producers and consumers.
Indian Pharmaceutical Industry; its Challenges WHILE Exportation of pharmaceu...Manukonda sravani Reddy
ย
The Indian pharmaceutical industry is currently the largest provider of generic drugs globally, accounting for 20% of global exports. It is expected to expand rapidly to reach $55 billion by 2020. The industry meets 70% of India's domestic drug demands and includes over 8,000 small companies and 250 large companies. India is the third largest pharmaceutical market by volume and exports over $16 billion worth of drugs annually, with the largest importer being Europe. Pharmaceutical companies in India are regulated by the Drugs and Cosmetics Act and must obtain regulatory approval through various procedures to market drugs in India and other countries.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
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Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
REGULATORY REQUIREMENTS OF EU, MHRA, TGA AND RoW COUNTRIESDhruvi Panchal
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The document summarizes the key regulatory requirements for medicines in the European Union (EU), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Australia's Therapeutic Goods Administration (TGA), and countries around the world (RoW). It discusses the roles of the European Medicines Agency (EMA) in the EU for scientific evaluation and marketing authorization of medicines. It also outlines licensing requirements, clinical trials oversight, safety monitoring, and other regulatory processes in the EU, UK, Australia and various other countries.
Regulatory requirments of eu, tga & row countriesGeetaKhillari
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The document summarizes regulatory requirements for pharmaceutical products in the EU, Australia (TGA), and rest of world (ROW) countries. The EU system involves clinical trials approval at the member state level and marketing authorization from both member states and the centralized European Commission. The TGA regulates therapeutic goods in Australia to ensure quality, safety and efficacy. Regulations in ROW countries vary significantly between regions like Asia, Latin America, and others, but generally involve product registration and licensing with national regulatory agencies.
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS โ RECOMMENDATIONS 2005 โ KEY CHANGES
2006 CONSULTATIONS โ 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES โ FURTHER DEVELOPMENT
The document provides information about the Third International Conference for Improving Use of Medicines (ICIUM2011) which will be held from April 10-14, 2011 in Bibliotheca Alexandrina, Egypt. It discusses the goals of ICIUM conferences which are to improve medicine use and health, recommend evidence-based strategies, identify ways to monitor impacts, and develop a research agenda. The document outlines the conference structure, participating organizations, registration details, and calls for abstract submissions.
Medicines Verification Systems in Europe โ a perspective from wholesale distr...Lรกszlรณ รrvai
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The Falsified Medicines Directive and its Delegated Regulation on Safety Features
European Medicines Verification Organisation (EMVO) and the roll-out of National Medicines Verification Systems
GIRP and wholesale distributors perspectives on medicines verification systems
Impact on the actors in the supply chain
The document summarizes the establishment of an adverse drug reaction (ADR) monitoring program in Georgia according to World Health Organization guidelines and recommendations. The program was set up in 1997 through the Ministry of Health and collects reports of ADRs through both active and spontaneous reporting systems. It analyzes reported ADRs using international standards and reports them to the international drug monitoring center in Uppsala, Sweden. The goal of the program is to improve pharmacovigilance and drug safety in Georgia by monitoring drugs in the post-registration period and providing independent drug safety information to healthcare professionals and the public.
Overview of the regulatory system for medical devices in kenyaPaulyne Wairimu
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The regulatory landscape for medical devices has in recent years witnessed changes. This presentation gives an overview of the changes and the anticipated phased registration process of Medical Devices in kenya as regulatory system strengthening is developed.
GLOBAL HEALTH DIPLOMACY: CONTEMPORARY CHALLENGES AND PROSPECTS FOR UKRAINEVolodymyr Korolenko
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Viktor Liashko, Roman Isaienko, Volodymyr Korolenko.
Report at the International conference on the occasion of World Health Day 2023 and the 75th anniversary of WHO. Kyiv, Ukraine, Apr 6th, 2023
The document discusses and compares the drug approval processes of several countries, including the US, EU, Australia, China, and India. It outlines the key regulatory authorities and stages of approval for each region. The US process involves the FDA and stages of an Investigational New Drug Application, clinical trials, and a New Drug Application. The EU has a centralized process through the EMEA or decentralized/mutual recognition processes involving multiple member states. Each country or region has distinct requirements but generally aim to ensure safety, efficacy and quality of new drugs through clinical research and regulatory oversight.
Regulation of healthcare market in russian federationkshanmugaraj1997
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This document discusses state regulation of healthcare markets in the Russian Federation. It outlines the legal basis at both the federal and regional levels, including key pieces of federal legislation like the Constitution of the Russian Federation. It also discusses topics like marketing and promotion of healthcare services, commissioning and procurement processes, ownership of healthcare businesses, and the regulators involved like Roszdravnadzor.
This document reports on a project to build a platform for implementing Good Pharmacy Practice (GPP) standards in Macedonia. It describes the methodology used, which included surveys of community and hospital pharmacies. The results sections provide demographic data on the pharmacies surveyed and scores on indicators of pharmacy practice and services. The document concludes with recommendations to improve the legal, economic, and workforce frameworks to support higher standards of pharmacy practice in Macedonia.
The European Union has established a centralized system for regulating and approving pharmaceutical drugs. There are three main approval routes: the centralized route administered by the European Medicines Agency, the mutual recognition procedure, and the decentralized procedure. Stringent regulations were implemented following drug safety disasters to protect public health and ensure safe, effective medicines.
The document discusses pharmaceutical regulations in Romania. It notes that while Romanian legislation has been harmonized with EU law, pricing, reimbursement, and taxation are specifically regulated nationally. The legal framework is set by various laws and the regulations are interpreted and enforced by several competent authorities, most notably the Ministry of Health, National Health Insurance House, and National Agency for Medicines and Medical Devices. A marketing authorization is required to market pharmaceuticals in Romania, and the process involves national, decentralized, mutual recognition or centralized authorization procedures depending on the circumstances. Distribution is also regulated and may only be conducted by licensed wholesale distributors.
Minimum requirements for a functional pharmacovigilance systemPriti Gupta
ย
The document outlines minimum requirements for a functional national pharmacovigilance system. It defines pharmacovigilance and describes the development of minimum requirements through consultation with experts. The minimum requirements include: having a national pharmacovigilance center with dedicated staff and funding; a national system for spontaneous reporting of adverse drug reactions using a standard form; a national database for managing reports; a national advisory committee to provide technical assistance on assessing and managing risks; and a communication strategy for routine updates and crisis response.
2023.08.15_National Drug Polices_3rd years.pptxFranciKaySichu
ย
The document summarizes Zambia's national drug policy. Key points include:
- The policy aims to ensure equitable access to safe, effective and affordable essential medicines through regulation, quality control, education, and rational drug use.
- Key stakeholders in developing the policy are the Ministry of Health and other government departments.
- The policy addresses legislation, drug selection, procurement, storage, distribution, financing, local production, human resources and challenges like stockouts and irrational use.
- Implementation of the policy requires strengthening various institutions like the drug regulatory authority and improving challenges around staffing and funding.
Unitaid has funded several projects related to intellectual property for HIV, HCV, and TB medicines since 2010. The first project provided over $56 million to the Medicines Patent Pool to negotiate voluntary licenses for HIV medicines and expand to HCV and TB. Other projects supported using TRIPS flexibilities like opposition of patent applications in India, Argentina, Brazil, Thailand and Ukraine. Unitaid is funding these IP projects because patents can limit access and affordability of medicines or block appropriate formulations, and TRIPS flexibilities provide solutions. The funding aligns with Unitaid's mandate to support countries using compulsory licensing or other TRIPS flexibilities when IP barriers limit competition and price reductions.
DNDi was created in 2003 to develop new treatments for neglected diseases like HIV/AIDS, tuberculosis, and sleeping sickness that disproportionately impact developing countries. It was founded by MSF and partners including research institutes from India, Kenya, Brazil, and Malaysia. DNDi uses a patient-needs driven model and has delivered 7 new treatments through over 160 partnerships worldwide. Its goal is to deliver 16-18 new treatments by 2023 and establish a robust pipeline of treatments as global public goods.
This document discusses how social movements often start with a single person taking a stand at a pivotal moment, such as Mohamed Bouazizi in Tunisia, Nelson Mandela in South Africa, and Mahatma Gandhi in India. It notes that movements need funding to continue but is unclear whether getting funding should be the goal or if funding will come as a result of actions. The document raises getting funding as both something necessary and something that results from movements.
This document discusses a donor's perspective on funding to eliminate intellectual property barriers that restrict access to HIV treatment. It notes that the donor organization, Aidsfonds, provides 1-2 million euros annually for international projects. Past funding has increased capacity for intellectual property issues in several countries. The rationale for supporting this work is that medicine prices are key to treatment access and many people living with HIV are in middle-income countries. There is also a clear need as few donors support this type of work, which could have a high impact by changing national policies and reducing prices. The document outlines some dilemmas in obtaining funding and measuring the effects of intellectual property projects.
This document discusses the importance of intellectual property (IP) work to ensure access to HIV and HCV treatment. It provides the following key points:
1. IPPCru has been monitoring government drug procurement in Russia since 2010 and their analytical reports are now considered the best available on treatment access in the region.
2. While HIV treatment coverage in Russia has increased from 15-20% in 2013 to 35-40% in 2017, 600,000 people still need treatment. Price reductions of 60-85% have occurred for generic drugs but patents until 2030 prevent generics and price reductions for other drugs.
3. IP work is important to challenge patents like the SOF patent in Russia to help lower prices and
Civil society groups have increasingly used patent oppositions across the world to challenge drug patents and improve access to medicines. Before 2006, such challenges only occurred in two countries, but now take place in nearly 50 countries. Civil society plays a unique and important role by providing technical and legal expertise for cases, mobilizing communities, and advocating for public health over private interests. Successful challenges in India against HIV drugs resulted in price reductions of 51-89% and potential cost savings of $500 million for lower-income countries. From 2014-2017, a coalition's legal interventions on 7 HIV drugs expanded access. Coordinating challenges globally in 2015 increased their impact and strategy sharing. Overall, patent oppositions led by civil society have significantly increased
GSIPA2M, Roundtable 4, Challenging unmerited patents - Menna-t-allah M. El Ko...MakeMedicinesAffordable
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The document discusses Egypt's patent opposition process according to Law No. 82 of 2002. It outlines that within 60 days of an application being published, concerned parties can submit a written opposition notice stating their reasons. Oppositions are examined by a committee and must be accompanied by a fee between 100-1000 pounds. The patent office must also send copies of applications relating to defense, security, military or health matters to the relevant ministry, which have 90 days to oppose publication or granting of the patent. Finally, the administrative tribunal can modify or remove patent data or repeal patents granted in violation of conditions.
GSIPA2M, Roundtable 4, Challenging unmerited patents - Jose Maria di BelloMakeMedicinesAffordable
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The document discusses successes and challenges of civil society patent challenges in Argentina. It summarizes Fundaciรณn GEP's efforts to oppose patents and promote generic competition through legal challenges. This has led to significant price reductions for key HIV and hepatitis C medicines including Sofosbuvir. However, pharmaceutical companies continue submitting numerous patent applications, and civil society must defend patentability guidelines and promote the use of public interest safeguards in patent law.
Patent Oppositions: Improving access to treatment in Ukraine using TRIPS-flexibilities.
Presented by Sergey Kondratyuk, All Ukrainian Netowrk of People Living with HIV.
UNDP law reform and recommendations of UN High Level panel on Access to Medicines.
Presented by Judit Rius Sanjuan, UNDP HIV, Health and Development Group.
The document discusses how Least Developed Countries (LDCs) in the Southern African Development Community (SADC) region are making use of transition periods allowed under the TRIPS agreement to facilitate access to medicines. While LDCs are allowed to ignore pharmaceutical patents until 2033, there is little evidence they are using TRIPS flexibilities. A few have issued compulsory licenses but many register patents through ARIPO. Barriers include a lack of political will, conflicting stakeholder interests, and bilateral agreements overriding TRIPS flexibilities. The document recommends strengthening regional cooperation through regulatory harmonization, pooled procurement, and technology transfers to build local pharmaceutical production capacity before 2033 transition periods expire.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
ย
(๐๐๐ ๐๐๐) (๐๐๐ฌ๐ฌ๐จ๐ง ๐)-๐๐ซ๐๐ฅ๐ข๐ฆ๐ฌ
๐๐ข๐ฌ๐๐ฎ๐ฌ๐ฌ ๐ญ๐ก๐ ๐๐๐ ๐๐ฎ๐ซ๐ซ๐ข๐๐ฎ๐ฅ๐ฎ๐ฆ ๐ข๐ง ๐ญ๐ก๐ ๐๐ก๐ข๐ฅ๐ข๐ฉ๐ฉ๐ข๐ง๐๐ฌ:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
๐๐ฑ๐ฉ๐ฅ๐๐ข๐ง ๐ญ๐ก๐ ๐๐๐ญ๐ฎ๐ซ๐ ๐๐ง๐ ๐๐๐จ๐ฉ๐ ๐จ๐ ๐๐ง ๐๐ง๐ญ๐ซ๐๐ฉ๐ซ๐๐ง๐๐ฎ๐ซ:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
ย
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
ย
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
How to Make a Field Mandatory in Odoo 17Celine George
ย
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the bodyโs response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
ย
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analyticsโ feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
ย
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
ย
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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1. Eurasian Economic Union
โข Belarus, Kazakhstan, Kyrgyzstan, Russia
โข Established 1 January 2015
โข Fifth (sixth) economy in the world (according to different statistics)
โข Estimated volume of the pharmaceutical market: USD 32 bn
โข Seventh biggest pharmaceutical market in the world
โข About 70% of the medicines are imported
โข By 1 January 2016 โ single pharmaceutical market
Sources: Sites of the Eurasian Economic Union and the Commission
2. The Common Principles for Medicines
โข Agreement on the common principles and rules for turnover of
pharmaceuticals in the EAEU โ already signed
โข Includes pre- and clinical trials, registration, production, transport
across EAEU territory, import, quality control
โข Requires a rapid legislation harmonization
โข Unified registry for pharmaceuticals and electronic information
system
โข Likely practical implications for national healthcare systems, including
in ARVs
3. Association Agreements with the EU
โข Georgia, Moldova, Ukraine
โข Pharmaceutical markets: Georgia - about 230 mln; Moldova - about
185 mln; Ukraine - about 2.7 bln.
โข AA with FTAs concluded in 2014
โข All refer to the need to use the TRIPS Agreement public health
flexibilities, as re-stated in the Doha Declaration to access medicines
โข Also all include test data exclusivity
4. Data exclusivity requirements under AAs
Test data exclusivity
(no registration through
reliance)
Marketing exclusivity (can
register but cannot market)
Additional extensions
(new therapeutic
indications)
5
years
7
years
8
years
5. UNDP Analytical Report
โข In 2015: analytical report on the
regulatory status of ARVs in CIS+
Georgia and Ukraine (patent,
registration, licensing, treatment
guidelines) with policy
recommendations. In Russian
and English.
โข Synergy with BBPS analysis
โTreating more for less in EECA",
which also covers some Western
Balkan countries.